BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA

    MDR report key: 3191924 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03642
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    December 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE EXAMINATION REVEALED THAT THE THREAD WAS DAMAGED, SO A FASTENING ACCORDING TO RULES IS NO LONGER ENSURED. THE EXACT DEVELOPMENT OF THE DAMAGE COULD NOT BE ESTABLISHED. IT IS ASSUMED, HOWEVER, THAT THE INSTRUMENT WAS INSUFFICIENTLY OILED OR NOT OILED AFTER CLEANING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE THREAD OF THE REMOBILIZATION TOOL JAMMED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292900 REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA LXH SYNTHES GMBH 7505457

    Patients

    Seq Age Sex Outcome Treatment
    1